The decision may be one of the agency's longest, at 50,000 words (for me, 94 pages when clipped into Word). I tally 510 references cited. The conclusion is that there is only indefinite evidence of the benefit for Medicare patients in particular cases, and under such circumstances, decisions to cover surgery should be undertaken by local MACs rather than under an NCD. There is an interesting backstory to the 1980s; details after the break.

An initial non coverage decision against transsexual surgery was published in the Bush I administration, 1989 (see Federal Register August 1, 1989; 54:34555; 34572).

That Medicare noncoverage decision was based on a 1980 or 1981 assessment by the National Center for Healthcare Technology. At online detailed blog about that report is here. Until June 2, 2016, there has never been an updated evidence review at CMS.

In 2012/2013, a Medicare patient filed an appeal to overturn the NCD. While CMS could have withdrawn the NCD, or revised it, they chose not to do that; nor to "fight" the NCD appeal petition.[*] Department Appeals Board judges therefore moved ahead with their process, finding the NCD to be unsupported by evidence and not valid. The NCD was invalidated in May 2014. Since 2014, transsexual surgery has been decided - like any service that lacks an NCDs - by MACs. While there are CPT codes and ICD-10 codes that are relevant, to my knowledge no MAC has attempted to write an LCD on the topic.

The CMS tracking sheet for the new NCD is here. CMS opened it six months ago in December 2015, with 103 comments submitted. For the June 2016 proposed 90-page policy, public comments may be submitted for 30 days (until July 2, 2016; here. At top right of webpage see Comment button.) See link to Final Policy at top of this blog.

The request letter that triggered the policymaking, by one Nahael Shields, is here.
___
[*] CMS chose not to change the NCD but to let the administrative legal process run its course in front of a judicial panel without any interaction from the agency. However, they earlier had proposed to change the NCD and the proposal was taken down from the web after 1 day. More here.

While this was a simple NCD leaving everything to MAC discretion, I noticed there was a public comment offering a rather long "model NCD" for CMS to consider, here.
l

About the Author

Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.